Tsi

FDA UDI

Class II (US FDA UDI)

by Tedan Surgical Innovations, L.l.c.

Identity

Trade Name: TSI FDA UDI
Generic Name: Nerve-locating system probe, single-use FDA UDI
Device Name: INSULATED DILATOR, 22 MM, STERILE FDA UDI
Model / Reference: ML-0449S FDA UDI
Description: INSULATED DILATOR, 22 MM, STERILE FDA UDI

Identifiers

Primary DI / UDI-DI: 00851797006146 FDA UDI
510(k) Number: K140088 FDA UDI
FDA Product Code: PDQ FDA UDI
GMDN Term: Nerve-locating system probe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 22 Millimeter FDA UDI

Category: Nerve-locating system probe, single-use

Tsi by Tedan Surgical Innovations, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve-locating system probe, single-use.

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Cobra® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
SafeOp 3 — ALPHATEC SPINE, INC. · Class II
IOM Stimulator Probes — SPES MEDICA SPA · Class II
NIM-Spine® — MEDTRONIC SOFAMOR DANEK, INC. · Class II

Cleared under the same submission

K140088 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Tedan Surgical Innovations, L.l.c.

Sources (1)

FDA UDI 80d15ac9-55d0-4429-bc5f-9a1405664a92 35 fields · synced Jun 6, 2026